medical Class II Updated 2020-03-11

Polymer Technology Systems, Inc. recalls PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitr

Recalled Product

PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.


Hazard / Issue

The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 1811715 1831313 1831324 1831325
View official government recall

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